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FDA 510(k)

OP-FLEX SUMP SUCTION SET WITH DIFFUSER TIP

K-Number: K935531 · 1994-05-05

ApplicantPuritas Health Care, Inc.
Decision Date1994-05-05
Product CodeGBX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

OP-FLEX SUMP SUCTION SET WITH DIFFUSER TIP is the device name listed in this FDA 510(k) record. The listed applicant is Puritas Health Care, Inc.. It received FDA 510(k) clearance on 1994-05-05 under 510(k) number K935531. The device is classified under product code GBX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OP-FLEX SUMP SUCTION SET WITH DIFFUSER TIP?

OP-FLEX SUMP SUCTION SET WITH DIFFUSER TIP is a medical device that received FDA 510(k) clearance on 1994-05-05. The listed applicant is Puritas Health Care, Inc.. The 510(k) number is K935531.

When did OP-FLEX SUMP SUCTION SET WITH DIFFUSER TIP receive FDA 510(k) clearance?

OP-FLEX SUMP SUCTION SET WITH DIFFUSER TIP received FDA 510(k) clearance on 1994-05-05, under 510(k) number K935531.

Who is the listed applicant for OP-FLEX SUMP SUCTION SET WITH DIFFUSER TIP?

The FDA 510(k) record lists Puritas Health Care, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OP-FLEX SUMP SUCTION SET WITH DIFFUSER TIP?

The FDA product code for OP-FLEX SUMP SUCTION SET WITH DIFFUSER TIP is GBX.

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Other records listing Puritas Health Care, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K942339SKIN NEUVEAU SCAR TREATMENTK941197SILK*SKIN SCAR TREATMENTK935600TRACHEAL SUCTION CATHETERK940074Y-TYPE BLOOD ADMINISTRATION SETK940055MULTISETK940054MEASURED VOLUME SOLUTION ADMINISTRATION SET

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Related Devices (Code: GBX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K082725GRAFTGUARD PRESSURE CONTROLLING SYRINGEMaquet Cardiovascular, LLCK052286DEUTSCH ANTI-BLOCKAGE WOUND DRAINThe Catheter Exchange, Inc.K043515GRAFTSAVERVescare, Inc.K013417MISONIX IRRIGATION SYSTEM MOEDL BC20PMisonix, Inc.K000704DMC SAPHENOUS VEIN DISTENTION SYSTEM (SVDS)Dmc Medical, Ltd.K974233LYSONIX IRRIGATION SYSTEMLysonix, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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